Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study

O’Connor, Paul; Goodman, Andrew; Kappos, Ludwig; Lublin, Fred; Polman, Chris H.; Rudick, Richard A.; Hauswirth, Kathy; Cristiano, Lynda M.; Forrestal, Fiona; Duda, Petra W.

doi:10.1212/wnl.0000000000000541

Cited by 118 publications

(94 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…2,19,20 After discontinuation of natalizumab therapy, disease activity returned, with 21% of patients experiencing a relapse within 8 months of stopping treatment, 19 and disability, which had been stable for 2 years with natalizumab use, increased. 2 However, these data provided no information on whether the return of disease activity and disability progression could be mitigated by switching to alternative therapies. In the phase 4, randomized RESTORE trial, 21 which enrolled patients who were stable while taking natalizumab treatanother treatment.…”

Section: Sf-12 Pcs Changementioning

confidence: 99%

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies

Cofield

Fox²,

Tyry

et al. 2016

International Journal of MS Care

View full text Add to dashboard Cite

show abstract

Section: Sf-12 Pcs Changementioning

confidence: 99%

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies

Cofield

Fox²,

Tyry

et al. 2016

International Journal of MS Care

View full text Add to dashboard Cite

show abstract

“…In the respective pivotal clinical trials comparing active treatment to placebo, natalizumab monotherapy reduced annualized relapse rate (ARR) by 68% [9][10][11][12][13][14][15][16] compared to an around 30% reduction for IFN-b preparations and GA. Although these trials largely enrolled treatmentnaive patients, they were conducted in different epochs resulting in different absolute ARRs (ranging from 0.73 to 1.28 in the placebo groups).…”

mentioning

confidence: 99%

Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

et al. 2016

View full text Add to dashboard Cite

Background: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-b (IFNb)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries. Methods: The study population initiated IFN-b/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had $3 months of on-treatment follow-up, and had active RRMS, defined as $1 gadoliniumenhancing lesion on cerebral MRI at baseline or $1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensitymatched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n 5 366/group) and subgroups with higher baseline disease activity.Editorial, page 97 *These authors contributed equally to this work.

show abstract

“…Three risk factors for PML associated with natalizumab use have been identified: (1) positive serostatus for anti-JC virus (JCV) antibodies; (2) prior use of immunosuppressants; (3) duration of natalizumab therapy. 20 The overall PML incidence, as of June 3, 2015 22,23 Natalizumab use in pediatric MS was reported in several retrospective series. [24][25][26][27][28] In an Italian report of 55 cases, natalizumab was started at a mean age of 14.4 6 2.6 years after a mean disease duration of 25.5 6 19.2 months.…”

Section: -47%mentioning

confidence: 99%

Pediatric multiple sclerosis

et al. 2016

View full text Add to dashboard Cite

Over the last 20 years, there have been significant advances in multiple sclerosis (MS) therapeutics, with regulatory approval for 13 therapies in adults by the European Medicines Agency (EMA) and Food and Drug Administration. However, there is only limited approval for interferon-b and glatiramer acetate use in children 12 years and older by the EMA. Availability of diseasemodifying therapies to children and adolescents with MS is variable by region, and is extremely limited in some regions of the world. Up to 30% of children experience breakthrough disease requiring therapies beyond traditional first-line agents. Recent legislation in both the United States and Europe has mandated clinical studies for all new therapeutics applicable to children. Several clinical trials in children are underway that will provide important information regarding the efficacy and safety of newer drugs. This review summarizes the current knowledge of breakthrough disease, escalation, and induction treatment approaches in children with MS, especially pertaining to disease course and disability outcomes in this group of patients. In addition, ongoing clinical trials and approaches and challenges in conducting clinical trials in the pediatric population are discussed. Neurology ® 2016;87 (Suppl 2):S103-S109 GLOSSARY AOMS 5 adult-onset multiple sclerosis; ARR 5 annualized relapse rate; CI 5 confidence interval; EDSS 5 Expanded Disability Status Scale; EMA 5 European Medicines Agency; FDA 5 Food and Drug Administration; GA 5 glatiramer acetate; IFN 5 interferon; IPMSSG 5 International Pediatric MS Study Group; JCV 5 JC virus; MS 5 multiple sclerosis; NEDA 5 no evident disease activity; NMO 5 neuromyelitis optica; PIP 5 Pediatric Investigation Plan; PML 5 progressive multifocal leukoencephalopathy; POMS 5 pediatric-onset multiple sclerosis; PREA 5 Pediatric Research Equity Act.Over the last 20 years, there have been significant advances in multiple sclerosis (MS) therapeutics, with regulatory approval for 13 therapies in adults by the European Medicines Agency (EMA) and Food and Drug Administration (FDA).1 There is limited approval for interferon (IFN)-b and glatiramer acetate (GA) use in children $12 years of age by the EMA. Safety data for IFN-b-1a SC TIW (Rebif) for children .2 years of age is included in the European label. Availability of disease-modifying therapies to children and adolescents with MS is variable by region, and is extremely limited in some regions of the world. Several clinical trials in children are underway that will bring important information regarding the efficacy and safety of newer drugs (table 1). This review summarizes the current knowledge of breakthrough disease, escalation, and induction treatment approaches in children with MS, especially pertaining to disease course and disability outcomes in this group of patients.CONCEPTUAL APPROACHES TO TREATING CHILDREN WITH MS No evident disease activity (NEDA). The ultimate goal of therapy in MS is to prevent relapses and to halt disability accrual. The c...

show abstract

Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study

Abstract: This study provides Class III evidence that in patients with relapsing-remitting multiple sclerosis, natalizumab stabilizes EDSS scores, decreases relapse rates, and is associated with an increased risk of progressive multifocal leukoencephalopathy.

Cited by 118 publications

References 19 publications

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies

Disability Progression After Switching from Natalizumab to Fingolimod or Interferon Beta/Glatiramer Acetate Therapies

Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

Pediatric multiple sclerosis

Contact Info

Product

Resources

About